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Non-invasive Brain Stimulation

tDCS + CCFES for Stroke-related Hand Weakness

N/A

Recruiting

Led By David A Cunningham, PhD

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice

Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Awards & highlights

Study Summary

This trial will compare 3 non-invasive brain stimulation protocols to see which best helps stroke survivors regain hand movement through OT and PT.

Who is the study for?

This trial is for adults aged 21-90 who've had a stroke within the last 6-24 months, resulting in upper limb weakness but can still open their hand somewhat. They must be able to follow commands, remember things short-term, and sit unassisted. Excluded are those with seizure disorders, other neurological conditions, implanted electronic devices, pregnancy, recent Botox injections in the arm muscles or severe cognitive impairments.Check my eligibility

What is being tested?

The study tests three types of non-invasive brain stimulation combined with occupational therapy to improve hand movement after a stroke. Participants will receive either conventional tDCS (transcranial direct current stimulation), unconventional tDCS montages plus CCFES (Contralaterally Controlled Functional Electrical Stimulation), or sham tDCS plus CCFES.See study design

What are the potential side effects?

tDCS may cause mild side effects like itching or tingling at the electrode site on the scalp during application; headache; fatigue; nausea; and difficulty concentrating post-treatment. These are typically temporary and resolve soon after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my shoulder and elbow enough to use my hand for table tasks.

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I have weakness in one arm, making it hard to fully extend my fingers.

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My skin is unbroken on my weaker side's arm, hand, and head.

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I am between 21 and 90 years old.

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I can fully move and use my unaffected arm and hand.

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I can sit by myself in a chair without arms for the screening.

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I can extend my fingers and wrist by at least 10 degrees.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in uefm will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in uefm will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in uefm will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Box and Blocks Test (BBT)

Secondary outcome measures

Upper Extremity Fugl-Meyer Assessment (UEFM).

Other outcome measures

Neurophysiologic Assessments

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active conventional tDCS plus CCFESActive Control2 Interventions

The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

Group II: Active unconventional tDCS plus CCFESActive Control2 Interventions

The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

Group III: Sham tDCS plus CCFESPlacebo Group2 Interventions

The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor

114 Previous Clinical Trials

21,326 Total Patients Enrolled

David A Cunningham, PhDPrincipal InvestigatorMetroHealth Medical Center and Case Western Reserve University

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Active conventional tDCS montage plus CCFES (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05866003 — N/A

Weakness of the Upper Extremity Research Study Groups: Active conventional tDCS plus CCFES, Sham tDCS plus CCFES, Active unconventional tDCS plus CCFES

Weakness of the Upper Extremity Clinical Trial 2023: Active conventional tDCS montage plus CCFES Highlights & Side Effects. Trial Name: NCT05866003 — N/A

Active conventional tDCS montage plus CCFES (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05866003 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigative research open to individuals older than 35 years of age?

"As indicated by the eligibility criteria, participants in this clinical trial must be between 21 and 90 years of age. Alternatively, there are 51 medical trials for those younger than 18 and 1076 studies available to geriatric patients over 65."

Answered by AI

Is there still opportunity for enrolment in this research project?

"This investigation is not presently enlisting participants, according to the information posted on clinicaltrials.gov. The study was initially published on May 1st 2023 and edited lastly on May 9th of that same year. Although this trial isn't looking for candidates at present, there are 1116 other studies open to enrollees currently."

Answered by AI